secwatch.observer — SEC 8-K summary
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Issuer:     Coya Therapeutics, Inc. (COYA)
CIK:        0001835022
Form:       8-K
Filed at:   2025-07-01T23:59:59+00:00
Accession:  0001193125-25-153465
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Coya re-submits IND for COYA 302 ALS Phase 2 study after FDA request
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- Re-submitted IND to FDA on June 30, 2025, including requested non-clinical data.
- Previous FDA request on July 14, 2024, for additional non-clinical data.
- Plans to initiate Phase 2 study upon IND acceptance.
- Study: randomized, double-blind, placebo-controlled, 24-week with 24-week OLE, evaluating COYA 302 for ALS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835022/000119312525153465/0001193125-25-153465-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835022/000119312525153465/d17294d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-153465

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer